Clinical and Radiographic Evaluation of Partial Caries Removal in Permanent Molars Restored Using Giomer Compared to Resin Composite Restorations After 24 Months (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 主要终点
- Success rate
研究概览
简要总结
Dental manufacturers' constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.
详细描述
Giomer resin not only reduces the risk of secondary caries around restorations by releasing fluoride ions, but it also has good esthetic, physical, and handling features. Furthermore, advancements have been made to reduce giomer resin polymerization shrinkage by incorporating filler technology into the matrix system. As a result of these efforts, giomer resin is currently distinguished by its low shrinkage feature. According to the manufacturer, low shrinkage giomer resin has volumetric shrinkage of 0.8% and a polymerization shrinkage stress of 2.72 MPa. Several investigations were carried out to examine the overall clinical performance of low shrinkage giomer resin with equivalent success rates when compared to other restorative materials. The aim of the current study is to evaluate the effect of giomer in maintaining pulp health and dentin bridge formation after partial caries removal in permanent teeth with deep occlusal carious lesion when compared to resin composite restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria of participants:
- •18 -35 years.
- •Not received antibiotic therapy since 1 month before sampling.
- •Males or Females (Both genders).
- •Co-operative patients approving the trial.
- •Good to fair oral hygiene
- •Inclusion criteria of teeth:
- •Class I cavitated lesions in permanent molars (reaching >1/2 of the dentin on radiographic examination)
- •Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).
排除标准
- •Exclusion criteria of participants:
- •known allergic reaction to resinous materials.
- •Systemic disease or severe medical complications.
- •Periodontal problem.
- •Poor oral hygiene
- •Exclusion criteria of teeth:
- •Class II caries lesion
- •Shallow or enamel caries
- •Teeth with periapical lesions.
- •Mobile teeth, arrest caries and non-vital teeth
结局指标
主要结局
Success rate
时间窗: From enrollment to the end of treatment at 24 months
The primary outcome of the present clinical trial is success rate, expressed as a binary variable indicating whether the restored tooth maintained its pulp vitality after 24 months. Success will be evaluated by a positive response to cold pulp testing, absence of spontaneous pain, no tenderness to percussion, absence of periapical radiolucency.
次要结局
- Dentin bridge formation(From enrollment to the end of treatment at 24 months)
研究者
Omar Shaalan
Associate professor of conservative dentistry
NewGiza University